🏥 Medical Devices • 6,554 recalls
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Philips Medical Systems (Cleveland)
There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p
Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
Philips Medical Systems (Cleveland)
A pinch point at the end of the table top can cause injury.
Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.
There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.
GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
Radiometer America
RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane.
Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.
Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.
GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.